MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; RESPIRATOR,SURGICAL

Lot Number 6052004083

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Date 04/27/2020

Event Type  malfunction  

Event Description

The facemasks caused breakouts on several employees.Facemask with earloops from medline.Lot: 6052004083.Ref non27373.

• Type of Device: RESPIRATOR,SURGICAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 10046557
• MDR Text Key: 190658084
• Report Number: 10046557
• Device Sequence Number: 1
• Product Code: MSH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 6052004083
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/04/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1